TCTN: Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT02455141

Collaborator

(none)

970

Enrollment

Locations

Arms

101

Anticipated Duration (Months)

35.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm	Drug: Epirubicin plus Cyclophosphamide Drug: Taxanes Drug: Taxanes plus Carboplatin	Phase 3

Detailed Description

This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

970 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial

Actual Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Taxanes Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel	Drug: Epirubicin plus Cyclophosphamide Epirubicin 90mg/m2, d1, q3w4 Cyclophosphamide: 600mg/m2, d1, q3w4 Other Names: EC Drug: Taxanes Paclitaxel: 80mg/m2, d1, qw12 or Docetaxel: 80-100mg/m2,d1,q3w4
Experimental: Taxanes plus carboplatin Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin	Drug: Epirubicin plus Cyclophosphamide Epirubicin 90mg/m2, d1, q3w4 Cyclophosphamide: 600mg/m2, d1, q3w4 Other Names: EC Drug: Taxanes plus Carboplatin Paclitaxel: 80mg/m2, d1,d8,d15, q4w4 Carboplatin AUC=2, d1,d8,d15, q4w4 or Docetaxel: 75mg/m2,d1,q3w4 plus Carboplatin AUC=5-6, d1, q3w4

Arm

Intervention/Treatment

Active Comparator: Taxanes

Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel

Drug: Epirubicin plus Cyclophosphamide

Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4

Other Names:

Drug: Taxanes

Paclitaxel: 80mg/m2, d1, qw*12 or Docetaxel: 80-100mg/m2,d1,q3w*4

Experimental: Taxanes plus carboplatin

Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin

Drug: Epirubicin plus Cyclophosphamide

Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4

Other Names:

Drug: Taxanes plus Carboplatin

Paclitaxel: 80mg/m2, d1,d8,d15, q4w*4 Carboplatin AUC=2, d1,d8,d15, q4w*4 or Docetaxel: 75mg/m2,d1,q3w*4 plus Carboplatin AUC=5-6, d1, q3w*4

Outcome Measures

Primary Outcome Measures

Disease-free survival [3 years]
to compare the disease-free survival among two treatment arms

Secondary Outcome Measures

Overall Survival [3 years]
to compare the overall survival among two treatment arms
Incidence of neutropenia fever [up to 7 months]
to compare the neutropenia fever among two treatment arms
Incidence of grade 3-4 side effects [up to 7 months]
to compare the grade 3-4 side effects among two treatment arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria

Histologically confirmed adenocarcinoma of the breast, completely tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer. Triple-negative disease is defined as ER <10% positivity, PgR <10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);
Adequate bone marrow function
Adequate liver and renal function
Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

Prior systemic of breast cancer, including chemotherapy;
Metastatic breast cancer;
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
Contraindication for using dexamethasone;
History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP>180 mmHg or diastolic BP>100 mmHg);
Has peripheral neuropathy no less than grade 1;
Patient is pregnant or breast feeding;
Patients with psychiatric disorder or other diseases leading to incompliance to the therapy;
Known severe hypersensitivity to any drugs in this study;
Treatment with any investigational drugs within 30 days before the beginning of study treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuding Hospital	Fuding	Fujian	China
2	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005
3	Quanzhou First Hospital	Quanzhou	Fujian	China
4	Foshan No.1 People's Hospital	Foshan	Guangdong	China	528000
5	Guangdong Maternal and Child Health Care Hospital	Guangzhou	Guangdong	China	510000
6	Cancer Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang	China	150081
7	Jiangsu Jiangyin People's Hospital	Jiangyin	Jiangsu	China	214400
8	The First People's Hospital of Wujiang District	Suzhou	Jiangsu	China	215200
9	Yancheng Hospital of TCM	Yancheng	Jiangsu	China
10	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai	China	200021
11	Shanghai JiaoTong University School of Medicine, Ruijin Hospital	Shanghai	Shanghai	China	200025
12	Central Hospital of Huangpu District, Shanghai	Shanghai	Shanghai	China
13	Shanghai International Peace Maternal and child health care hospital	Shanghai	Shanghai	China
14	The Ninth People's Hospital of Shanghai	Shanghai	Shanghai	China
15	Hangzhou Cancer Hospital	Hangzhou	Zhejiang	China
16	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang	China
17	Jiaxin Maternal and Child Health Care Hospital	Jiaxin	Zhejiang	China	310000
18	Lishui People's Hospital	Lishui	Zhejiang	China	310000
19	Ningbo Medical Treatment Center Lihuili Hospital	Ningbo	Zhejiang	China	315000
20	Ningbo Women and Children's Hospital	Ningbo	Zhejiang	China	315000
21	Ningbo First Hospital	Ningbo	Zhejiang	China
22	Rui'an People's Hospital	Rui'an	Zhejiang	China	325200
23	Shaoxing Shangyu People's Hospital	Shaoxing	Zhejiang	China	312300
24	Shaoxing No.2 Hospital	Shaoxing	Zhejiang	China
25	Taizhou Central Hospital	Taizhou	Zhejiang	China	318000
26	Wenzhou People's Hospital	Wenzhou	Zhejiang	China
27	Zhoushan Hospital	Zhoushan	Zhejiang	China	316000